ClinicalTrials.gg
RecruitingNCT07846410HypnoVR-SCIUpdated Nov 3, 2026

Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury

An interventional study of Virtual Reality-Based Hypnotherapy and Conventional Physiotherapy in Spinal Cord Injuries (SCI), Chronic Pain and Neuropathic Pain, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Nov 3, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 62 studies in Spinal Cord Injuries with a site in Turkey — 16 open to participants now, 18 under way, 1 of them phase 3. Spinal Cord Injuries · Turkey.

Planned enrollment
10th of 31
40 · median 34
Started
2026
with 9 others
No phase
29 of 62
10 open now
Primary completion
2026-11
later than 13 of 17 live
Registered
60th of 62
by date
Lead sponsor
6 of 62
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Among the 62 studies in Spinal Cord Injuries with a site in Turkey, this one is the 10th largest by planned enrollment of the 31 interventional ones that give a count, is one of 10 that started in 2026, is one of 29 with no phase, reaches primary completion later than 13 of the 17 other live ones, and was the 60th registered.

Spinal Cord Injuries

2,026 studies on the registry are indexed under Spinal Cord Injuries; 538 are open to participants now.

Browse Spinal Cord Injuries studies →

Open to participants now

16 of the 62 studies in Spinal Cord Injuries with a site in Turkey are open now. Recruiting first, the newest first:

10 more — sign in →

All 16 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 62 studies in Spinal Cord Injuries with a site in Turkey, or all of them as a file.
02

Study summary

The goal of this clinical trial is to learn whether virtual reality (VR)-based hypnotherapy, added to conventional physiotherapy, improves pain, sleep, mood, and quality of life in adults with chronic spinal cord injury.

The main questions it aims to answer are:

  • Does VR-based hypnotherapy added to physiotherapy reduce pain intensity more than physiotherapy alone?
  • Does it improve neuropathic pain, sleep quality, anxiety and depression, spasticity, and quality of life?

Researchers will compare participants who receive VR-based hypnotherapy in addition to physiotherapy with participants who receive physiotherapy alone.

Participants will:

  • Receive a standard physiotherapy and rehabilitation program 5 days a week for 2 weeks (10 sessions).
  • If assigned to the VR group, also receive an approximately 20-minute VR-based hypnotherapy session after each physiotherapy session, using a VR headset and headphones.
  • Complete assessments at the start of the study, at the end of the 2-week treatment period, and 2 weeks after treatment ends.
Read the detailed description

Background and Rationale Pain is one of the most common and disabling consequences of spinal cord injury (SCI) and negatively affects functional status, sleep, emotional well-being, and quality of life. Pharmacological treatments are often insufficient or limited by side effects, and there is a need for safe, non-invasive, non-pharmacological adjunct therapies. Virtual reality (VR) may reduce pain through attentional redirection and immersion, while hypnotherapy may modulate pain perception through relaxation and cognitive reprocessing of pain. VR-based hypnotherapy combines these mechanisms and has shown short-term benefits in chronic musculoskeletal pain; however, its effects in individuals with SCI have not been investigated in a randomized controlled trial.

Study Design This is a prospective, randomized controlled, parallel-group, single-center, single-blind trial. A total of 40 patients with SCI will be enrolled. Participants will be allocated to two groups by computer-generated randomization: (1) intervention group, receiving VR-based hypnotherapy in addition to conventional physiotherapy; (2) control group, receiving conventional physiotherapy alone.

Interventions Both groups will receive a standard physiotherapy and rehabilitation program, 5 days per week for 2 weeks (10 sessions in total). Participants in the intervention group will additionally receive an approximately 20-minute VR-based hypnotherapy session following each physiotherapy session. Sessions will be delivered in a quiet clinical setting using a VR headset and headphones. The number of sessions completed and session duration will be recorded for each participant.

Baseline Data Sociodemographic characteristics, injury etiology and duration, comorbidities, complications, and current analgesic and antispastic medication use will be recorded. Neurological level and severity of injury will be classified according to the American Spinal Injury Association (ASIA) Impairment Scale.

Blinding Outcome assessments will be performed by a trained assessor blinded to group allocation. Due to the nature of the intervention, participants and therapists cannot be blinded.

Assessment Time Points Assessments will be conducted at baseline (T0), at the end of the 2-week intervention (T1), and 2 weeks after the end of the intervention (T2).

Safety Adverse events, including VR-related symptoms such as dizziness or nausea, will be recorded throughout the intervention period.

Statistical Analysis Data will be analyzed using SPSS. Descriptive statistics will be presented as mean, standard deviation, frequency, and percentage. Normality will be assessed using the Kolmogorov-Smirnov test. Between-group comparisons will be performed using the independent samples t-test or the Mann-Whitney U test, as appropriate. Changes over time will be analyzed using appropriate repeated-measures analyses. Statistical significance will be set at p\<0.05.

03

Conditions studied

  • Spinal Cord Injuries (SCI)
  • Chronic Pain
  • Neuropathic Pain
  • Sleep Disturbance
  • Depression

Keywords

  • Virtual Reality
  • Hypnosis
  • Hypnotherapy
  • Virtual Reality Hypnosis
  • Paraplegia
  • Tetraplegia
  • Rehabilitation
  • Physiotherapy
  • Quality of Life
  • Anxiety
  • Non-pharmacological Pain Management
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 18 and 65 years
  • Diagnosis of spinal cord injury
  • Injury duration longer than 3 months
  • (MMSE) score above 24
  • Willingness to participate and provision of written

Exclusion criteria

Exclusion Criteria:

  • Injury duration shorter than 3 months
  • Significant change in analgesic treatment within the last 3 months
  • Visual or hearing impairment
  • Epilepsy
  • Severe psychiatric illness (psychosis, severe major depression, or bipolar disorder in the acute phase)
  • Pregnancy
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    VR-Based Hypnotherapy + Conventional Physiotherapy

    Participants will receive a standard physiotherapy and rehabilitation program 5 days per week for 2 weeks (10 sessions). In addition, following each physiotherapy session, they will receive an approximately 20-minute virtual reality (VR)-based hypnotherapy session delivered in a quiet clinical setting via a VR headset and headphones (10 VR sessions in total).

    Behavioral: Virtual Reality-Based Hypnotherapy · Other: Conventional Physiotherapy

  • Active comparator
    Conventional Physiotherapy

    Participants will receive the same standard physiotherapy and rehabilitation program 5 days per week for 2 weeks (10 sessions), without VR-based hypnotherapy.

    Other: Conventional Physiotherapy

Interventions

  • BehavioralVirtual Reality-Based Hypnotherapy

    An immersive, audio-guided hypnotherapy session delivered through a virtual reality headset and headphones, combining visual immersion with hypnotic induction, relaxation, and pain-modulating suggestions. Each session lasts approximately 20 minutes and is administered immediately after the physiotherapy session, 5 days per week for 2 weeks (10 sessions in total), in a quiet clinical setting.

    Also known as: VR Hypnosis, VR-Mediated Hypnotherapy

  • OtherConventional Physiotherapy

    A standard physiotherapy and rehabilitation program for spinal cord injury, applied 5 days per week for 2 weeks (10 sessions in total), identical in both study arms.

06

What researchers measure

Primary outcomes

  1. Change in Pain Intensity (Numeric Rating Scale)

    Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. The change from baseline to the end of the intervention will be compared between groups.

    Time frame: Baseline and end of the 2-week intervention (week 2)

Secondary outcomes

  1. Pain Intensity at Follow-up (Numeric Rating Scale)

    Pain intensity will be assessed using the NRS (0-10). Higher scores indicate greater pain intensity. The persistence of the effect will be evaluated at follow-up.

    Time frame: Baseline and 2 weeks after the end of the intervention (week 4)

  2. Neuropathic Pain (DN4 Questionnaire)

    Neuropathic pain will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire, with total scores ranging from 0 to 10. Higher scores indicate a greater likelihood and burden of neuropathic pain features.

    Time frame: Baseline, week 2 (end of intervention), and week 4 (follow-up)

  3. Sleep Quality (Pittsburgh Sleep Quality Index)

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), with global scores ranging from 0 to 21. Higher scores indicate poorer sleep quality.

    Time frame: Baseline, week 2 (end of intervention), and week 4 (follow-up)

  4. Anxiety (Hospital Anxiety and Depression Scale - Anxiety Subscale)

    Anxiety will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), with scores ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms.

    Time frame: Baseline, week 2 (end of intervention), and week 4 (follow-up)

  5. Depression (Hospital Anxiety and Depression Scale - Depression Subscale)

    Depression will be assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D), with scores ranging from 0 to 21. Higher scores indicate more severe depressive symptoms.

    Time frame: Baseline, week 2 (end of intervention), and week 4 (follow-up)

  6. Spasticity (Modified Ashworth Scale)

    Spasticity will be assessed using the Modified Ashworth Scale (MAS), graded as 0, 1, 1+, 2, 3, and 4. Higher grades indicate greater muscle tone.

    Time frame: Baseline, week 2 (end of intervention), and week 4 (follow-up)

  7. Health-Related Quality of Life (EQ-5D-5L)

    Health-related quality of life will be assessed using the EQ-5D-5L, including the five-dimension index score and the EQ Visual Analogue Scale (EQ-VAS, 0-100). Higher index and EQ-VAS scores indicate better health status.

    Time frame: Baseline, week 2 (end of intervention), and week 4 (follow-up)

  8. System Usability (System Usability Scale)

    Usability of the VR-based hypnotherapy system will be assessed in the intervention group only using the System Usability Scale (SUS), with scores ranging from 0 to 100. Higher scores indicate better usability.

    Time frame: End of the 2-week intervention (week 2)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Louras M, Vanhaudenhuyse A, Panda R, Rousseaux F, Carella M, Gosseries O, Bonhomme V, Faymonville ME, Bicego A. Virtual Reality Combined with Mind-Body Therapies for the Management of Pain: A Scoping Review. Int J Clin Exp Hypn. 2024 Oct-Dec;72(4):435-471. doi: 10.1080/00207144.2024.2391365. Epub 2024 Sep 30. PubMed 39347979 ↗
  • Jones HG, Rizzo RRN, Pulling BW, Braithwaite FA, Grant AR, McAuley JH, Jensen MP, Moseley GL, Rees A, Stanton TR. Adjunctive use of hypnosis for clinical pain: a systematic review and meta-analysis. Pain Rep. 2024 Sep 10;9(5):e1185. doi: 10.1097/PR9.0000000000001185. eCollection 2024 Oct. PubMed 39263007 ↗
  • Menekseoglu AK, Asik HK, Sahbaz T, Is EE. Mind over pain: VR-based hypnotherapy for chronic non-specific low back pain - a randomised controlled trial. Ir J Med Sci. 2026 Feb;195(1):177-185. doi: 10.1007/s11845-025-04158-1. Epub 2025 Nov 10. PubMed 41212507 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data underlying the results reported in the publication will be shared upon reasonable request to the principal investigator.

Supporting information: Study protocol

Time frame: Beginning 6 months after publication of the main results and ending 5 years after publication.

Access criteria: Data will be shared with qualified researchers who provide a methodologically sound proposal, following approval by the principal investigator and a signed data use agreement.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Nov 2026, 1 month after the start.

Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 1 month is below that.

Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2026
First posted
Sep 29, 2026
StartActual
Oct 1, 2026
Primary completionEst.
Nov 2026
CompletionEst.
Dec 2026
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 3, 2026
Sites
Istanbul Physical Medicine and Rehabilitation Training and research Hospital is now Recruiting
Nov 3, 2026
Registered
First appeared on the registry
Sep 29, 2026
Show all 2 updates
  1. Nov 3, 2026
    Not yet recruiting→Recruiting
    Istanbul Physical Medicine and Rehabilitation Training and research Hospital is now Recruiting
    + 2 other changes: verification date and date precision
  2. Sep 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07846410
Responsible party
Selim Sezikli (Specialist in Physical Medicine and Rehabilitation, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospital) — Principal investigator
First posted
Sep 29, 2026
Start date
Oct 1, 2026
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 3, 2026

Study contacts

Selim Sezikli, MD
Contact
selimsezikli@hotmail.com
+90 506 510 18 33
Selim Sezikli, MD
principal investigator · Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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